As reported in the Journal of Clinical Oncology by Gallamini et al, the final analysis of the phase III GITIL/FIL HD0607 trial has shown that consolidation radiotherapy did not improve progression-free survival vs no further treatment in patients with advanced Hodgkin lymphoma and a baseline large nodal mass in complete metabolic response after treatment with ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine).
Study Details
The primarily Italian trial included 296 patients with stage IIB to IVB Hodgkin lymphoma with a negative positron-emission tomography (PET) scan after two (PET-2) and six (PET-6) cycles of ABVD who had a large nodal mass at baseline (nodal mass with the largest diameter ≥ 5 cm). Patients were randomly assigned to receive consolidation radiotherapy (median dose = 30.6 Gy) to the large nodal mass (n = 148) or no further treatment (control group, n = 148).
“Consolidation radiotherapy could be safely omitted in patients with Hodgkin lymphoma presenting with a large nodal mass and a negative PET-2 and PET-6 scan, irrespective from the large nodal mass size detected at baseline.”— Gallamini et al
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Key Findings
Among the 296 patients, the largest diameter of a large nodal mass at baseline was 5–7 cm in 101 (34% [subgroup A, including 56 in the consolidation radiotherapy group vs 45 in the control group]), 8–10 cm in 96 (32% [subgroup B, including 43 vs 53 patients]), and >10 cm (classic bulky disease) in 99 (33% [subgroup C, including 49 vs 50 patients]).
After median follow-up of 5.9 years (range = 0.5–10 years), 6-year progression-free survival on intent-to-treat analysis was 92% in the consolidation radiotherapy group vs 90% in the control group (P = .48). The 6-year progression-free survival rates were 91% vs 95% (P = .62) in subgroup A, 98% vs 90% (P = .24) in subgroup B, and 89% vs 86% (P = .53) in subgroup C.
Overall, 280 patients (88%) had a postchemotherapy residual mass. Among these patients, the relapse rate was 7% in the consolidation radiotherapy group vs 9% in the control group. Progression-free survival at 6 years was 93% vs 89% (P = .41).
The 6-year overall survival rate on intent-to-treat analysis was 99% vs 98% (P = .61).
The investigators concluded, “Consolidation radiotherapy could be safely omitted in patients with Hodgkin lymphoma presenting with a large nodal mass and a negative PET-2 and PET-6 scan, irrespective [of] the large nodal mass size detected at baseline.”
Andrea Gallamini, MD, of the Department of Research and Innovation, Lacassagne Cancer Center, Nice, France, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was supported by the Associazione Italiana per la Ricerca sul Cancro, Associazione Italiana Lotta alla Leucemia, and others. For full disclosures of the study authors, visit ascopubs.org.
